Hyperphosphatemia
Conditions
Keywords
Tenapanor, Hyperphosphatemia, Hemodialysis
Brief summary
To evaluate the efficacy of KHK7791 by comparing changes in serum phosphorus levels from baseline values between hemodialysis patients with hyperphosphatemia receiving repeated administration of KHK7791 for 8 weeks and those receiving placebo.
Interventions
DRUGKHK7791
oral administration
DRUGPlacebo
oral administration
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Has voluntarily provided written informed consent to participate in the study. 2. Aged ≥ 20 years (expressed in completed years) at the time of providing informed consent. 3. Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination. 4. Dialysis conditions (dialysate, dialyzer, frequency of dialysis per week, dialysis duration, blood flow rate, and dialysate and substitution fluid flow rates), excluding dry weight, should have been unchanged during the last 2 weeks before screening examination. 5. The prescribed drug and dosage regimen should have been unchanged during the last 4 weeks before screening examination. 6. Serum phosphorus levels should be in the range of ≥ 3.5 and ≤ 6.0 mg/dL at screening examination. 7. If on any vitamin D, calcimimetics regimen, bisphosphonate, calcitonin preparations, selective estrogen receptor modulators or teriparatide preparations then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination. 8. Kt/V urea ≥ 1.2 at the most recent test in routine medical practice before screening examination.
Exclusion criteria
1. Peritoneal dialysis was performed within 12 weeks before screening examination. 2. iPTH \>600 pg/mL (should be based on the most recent value from the patients' medical records, etc. before pre-enrollment) 3. Having concurrent or a history of inflammatory bowel disease (IBD) or diarrhea-predominant irritable bowel syndrome 4. History of gastrectomy or enterectomy or having undergone gastrointestinal tract surgery within 3 months before screening examination. 5. Subjects who used anti RANKL preparations within 6 weeks before screening examination. 6. Subjects who used anti-sclerostin antibody preparations within 12 weeks before screening examination. 7. Having concurrent severe heart disease or hepatic impairment. 8. Developed cerebrovascular disease or cardiovascular disease requiring hospitalization within 6 months before screening examination. 9. Uncontrollable hypertension or diabetes. 10. Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis, or change in the dialysis center during the study period. 11. Any diagnosis of and treatment of malignancy within 5 years before screening examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration. | Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 6.0). | Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8. |
| Time when the target serum phosphorus level (serum phosphorus level: ≤ 6.0) was achieved. | Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8. |
| Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 5.5). | Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8. |
| Changes in serum phosphorous levels from baseline values at each time point. | Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8. |
| Concentrations of such as Ca × P product levels at each time point. | Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8. |
| Changes of such as Ca × P product levels from baseline values at each time point. | Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8. |
| Time when the target serum phosphorus level (serum phosphorus level: ≤ 5.5) was achieved. | Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8. |
Countries
Japan
Outcome results
None listed